Naloxegol US PMR CV Safety.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02813356|
Recruitment Status : Active, not recruiting
First Posted : June 27, 2016
Last Update Posted : August 28, 2020
|Condition or disease||Intervention/treatment|
|Opioid Induced Constipation||Drug: naloxegol Drug: non-PAMORA|
The primary objective is to assess the overall risk of major adverse cardiovascular events (MACE) among naloxegol-treated patients compared to that among patients on prescription non-peripherally acting mu-opioid antagonist (PAMORA) opioid induced constipation (OIC) treatment. The corresponding analysis is of a new-user cohort study that captures the occurrence of MACE in persons receiving naloxegol or comparison medications. The study takes place in actual-use settings in the US in which existing electronic data captures patient diagnoses, health care, and treatment. The occurrence of MACE in naloxegol-treated patients will be compared to the occurrence of MACE in medically-similar new users of other prescription-only treatments for OIC in the same settings, with both naloxegol-treated and comparison medication-treated patients being followed for as long as they continue on therapy.
In further pursuit of the primary objective, there will be a self-controlled study that follows all members of the new-user cohorts, including both new naloxegol users and new users of comparator products, for as long as data are available as the patients may go on or off treatment. A self-controlled study offers a complementary approach to the statistical control for the possible confounding effects of personal characteristics. Using the same data sources, this self-controlled design follows individuals from the time they finish their first course of treatment as new users for as long as the study continues. Patient treatment statuses are continuously updated since the treatment choices exercised by patients and their caregivers create extended periods of study time on and off naloxegol and possibly on and off other therapies for OIC. Comparisons of the occurrence of MACE occur within individuals and so are unaffected by differences between individuals, as in a crossover trial.
The first secondary objective is to assess the potential confounding effects of lifestyle risk factors on relative risk of MACE among naloxegol-treated patients compared with that among patients on other prescription non-PAMORA OIC treatment. The corresponding analysis is of a case-control study nested within the primary study population. All of the MACE "cases" will be matched to other members of the cohorts ("controls"). In cases and controls, the outpatient medical record will be abstracted for information on lifestyle risk factors. The case-control analysis will provide information on the presence and effect of lifestyle confounding factors that may be identifiable only by chart review.
Further secondary analyses will investigate the relative risks analyzed under an intent-to-treat paradigm over fixed time periods of membership in the naloxegol and comparator cohorts, relative risks for specific components of MACE, relative risks associated with new oral PAMORA agents other than naloxegol (non-naloxegol oral PAMORAs [NNPAMORAs]) that may come onto the US market during the course of the study, and an exploration of the possible variations in risk associated with variations in the dose and timing of naloxegol dispensing in the case-control study.
|Study Type :||Observational|
|Estimated Enrollment :||8800 participants|
|Official Title:||United States Post-Marketing Observational Cardiovascular Safety Study in Patients Taking Naloxegol|
|Actual Study Start Date :||June 24, 2016|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
patients exposed to naloxegol
non-interventional study where naloxegol is prescribed during normal clinical practice
patients exposed to non-peripherally acting mu-opioid antagonist
non-interventional study where patients are exposed to non-peripherally acting mu-opioid antagonists during the normal course of clinical practice
- major adverse cardiovascular events [ Time Frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 8 years ]while exposed to naloxegol or comparator exposure, composite of major adverse cardiovascular events which includes cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813356
|United States, Delaware|
|Wilmington, Delaware, United States, 19803|
|United States, Illinois|
|Hines, Illinois, United States, 60141|